Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992496
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date September 3, 2019
Actual Study Start Date  ICMJE April 24, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2016)
Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2016)
  • Clinician Administered Dissociative States Scale (CADSS) [ Time Frame: 2 weeks ]
  • Hamilton Depression Rating Scale [ Time Frame: 1 week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
Official Title  ICMJE Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
Brief Summary The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Episode
Intervention  ICMJE
  • Drug: Ketamine
    1mg/kg, 6 applications over 2 weeks
  • Drug: Midazolam Hydrochloride
    0.03mg/kg, 6 applications over 2 weeks
Study Arms  ICMJE
  • Active Comparator: Ketamine treatment group
    Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.
    Intervention: Drug: Ketamine
  • Active Comparator: Control group
    Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks
    Intervention: Drug: Midazolam Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
  • Hamilton depression rating scale score ≥ 19
  • Willingness and competence to sign the informed consent form
  • Stable psychopharmacological treatment for 10 days (except benzodiazepines)

Exclusion Criteria:

  • Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
  • Prior use of ketamine
  • Pregnancy/Breast feeding
  • Instable arterial hypertension >170/110mmHg
  • Hepatic dysfunction
  • Hyperthyreosis
  • History of glaucoma
  • Neurodegenerative disorders
  • Any unstable medical illness
  • History of substance abuse within the past 12 months
  • History of psychosis
  • Failure to comply with the study protocol or to follow the instructions of the investigating team
  • Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02992496
Other Study ID Numbers  ICMJE v1.2_20161024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rupert Lanzenberger, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP